The Pharmacovigilance Risk Assessment Committee (PRAC) has published the European so-called ‘mandatory’ list of medicines under additional monitoring.  Additional monitoring status is always applied to a medicine in the following cases:

  • it contains a new active substance authorised in the EU after 1 January 2011
  • it is a biological medicine, such as a vaccine or a medicine derived from plasma (blood), for which there is limited post-marketing experience
  • it has been given a conditional approval (where the company that markets the medicine must provide more data about it) or approved under exceptional circumstances (where there are specific reasons why the company cannot provide a comprehensive set of data)
  • the company that markets the medicine is required to carry out additional studies, for instance, to provide more data on long-term use of the medicine or on a rare side effect seen during clinical trials

 

The additional monitoring list will replace the black triangle list previously published each month by the MHRA and will be published monthly on the MHRA website at www.mhra.gov.uk/blacktriangle. It will also available on the European Medicines Agency website. For information and principles of the additional monitoring scheme please refer to the Good Vigilance Practice Module X (external link).

 

Requirements for Marketing Authorisation holders

 

For centrally authorised products, The EMA have previously announced an updated product information template to label medicines subject to additional monitoring (external link) and an implementation plan (external link).   This guidance specifies that for new marketing applications, applicants shall implement the black symbol and statements (see below) about additional monitoring and encouragement to report adverse drug reactions by complying with the revised QRD template. For existing marketing authorisations, it is expected that marketing authorisation holders (MAHs) use the first upcoming regulatory procedure affecting Product Information Annexes to implement the black triangle, additional monitoring statement and other changes in the QRD template.  If no suitable regulatory procedure is identified, a type 1a variation should be submitted.  Any procedures implementing these changes should be completed no later than 31/12/2013.  The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) are due to discuss guidance and implementation timelines for Decentralised/Mutual recognition products and these will be published in due course.  The MHRA expects that MAHs will be asked to follow the Centrally Authorised products guidelines and timelines for Decentralised/Mutual recognition and nationally authorised products.

 

Transition from the UK Black Triangle list to the EU additional monitoring list

 

There are some differences between the Black Triangle list last published by the MHRA and that of the EU additional monitoring list published on 25 April 2013, which only includes products meeting the ‘mandatory’ reasons for inclusion.  An ‘optional’ scope list of further medicines that Competent Authorities have concluded to require additional monitoring is expected to be published later in 2013 once agreed by the PRAC.  Marketing authorisation holders should be aware that products which are not currently included in the initial EU additional monitoring list may be added (eg. reinstated from the UK black triangle list) later in 2013 once the final list is agreed by the PRAC.

 

For medicines previously listed as UK black triangle (according to the latest list published 19 March 2013) but not be present on the published ‘mandatory’ EU additional monitoring list, MAHs can remove black triangle status without contacting the MHRA. If you have any questions please contact blacktriangle@mhra.gsi.gov.uk.

 


SmPC wording

 

For medicinal products subject to additional monitoring ONLY:  The black symbol and the statements should only appear preceding section 1. The black symbol shall be a black inverted equilateral triangle: the symbol shall be proportional to the font size of the subsequent standardised text and in any case each side of the triangle shall have a minimum length of 5 mm. For the purpose of preparing the product information annexes please use the black triangle as presented in the template.

 

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.  See section 4.8 for how to report adverse reactions.

 

For ALL medicinal products: The following sub-heading should appear at the end of section 4.8

 

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

 

PIL wording

 

For medicinal products subject to additional monitoring ONLY: The black symbol and the statements should only appear immediately after the declaration of the name of the medicine. The black symbol shall be a black inverted equilateral triangle: the symbol shall be proportional to the font size of the subsequent standardised text and in any case each side of the triangle shall have a minimum length of 5 mm. For the purpose of preparing the product information annexes please use the black triangle as presented in the template.

 

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

 

For ALL medicinal products: The following sub-heading should appear at the end of section 4.

 

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

 

Posted on the UK MHRA Website on 25 April 2013